Intensive Glycemic Control and Skeletal Health Study

Hypertension Clinical Trial

— ACCORD-BONE  

Official title:

Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324350
• Other study ID #: R01DK069514
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: September 5, 2012
• Start date: October 2003
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.

Description:

Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7287
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

Inclusion criteria:

• Fulfills criteria for inclusion in the ACCORD main trial

• Must have been randomized into the ACCORD study and be a participant from the five CCNs in the ACCORD-BONE ancillary study.

Exclusion criteria:

• Fulfills criteria for exclusion in the ACCORD main trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
type 2 diabetes treatments, per standard of care

Locations

Country	Name	City	State
Canada	Population Health Research Institute	Hamilton	Ontario
United States	Case Western Reserve University	Cleveland	Ohio
United States	Veterans Affairs	Memphis	Tennessee
United States	Berman Center for Outcomes & Clinical Research	Minneapolis	Minnesota
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Schwartz AV, Margolis KL, Sellmeyer DE, Vittinghoff E, Ambrosius WT, Bonds DE, Josse RG, Schnall AM, Simmons DL, Hue TF, Palermo L, Hamilton BP, Green JB, Atkinson HH, O'Connor PJ, Force RW, Bauer DC. Intensive glycemic control is not associated with frac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Non-vertebral Fracture	The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.	Average follow-up of 3.8 years	No
Primary	Number of Participants With at Least One Fall	At each annual visit starting in January 2006, participants were also asked about falling: "In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?" Those who answered "yes" were also asked how many times they had fallen in the previous 12 months.	Average follow-up of 2.0 years	No
Secondary	Number of Participants With > 2 cm of Height Loss	Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing >2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity	5 years	No

External Links

•   ACCORD-BONE Sub-Study Website